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Post Traumatic Stress DisorderVWNCT03898271

PTSD Training for PCPs in a Virtual World

A study testing Virtual World in people with Post Traumatic Stress Disorder, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans often present to their primary care providers with symptoms of PTS and related physical problems; however, most primary care providers… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Post Traumatic Stress Disorder
What is being tested?
Virtual World
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Oct 2015to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Primary Care Providers (PCPs) currently practicing adult medicine (including licensed internists, family practitioners, nurse practitioners, physician assistants, allied health professionals and trainees working in Primary Care setting)
  • English-speaking

Who cannot join

  • Lack of sufficient time to participate in all required training sessions, homework and evaluations.
  • Lack of a computer capable of running the Virtual World software
  • Retired or retiring during the study period
  • Vision or hearing impaired or other disability precluding the use of a computer or telephone*
  • While this is an exclusionary criterion for this trial, prior to broader dissemination, at the conclusion of the study, we will make accommodations in the Virtual World training to make it Section 508-compliant for persons with disabilities.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Francisco VA Health Care System

    San Francisco, California, 94121

Other trials in United States

About this study

Official title: Improving Access to Care for Warfighters: Virtual Worlds Technology to Enhance Primary Care Training in Posttraumatic Stress and Motivational Interviewing

The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans often present to their primary care providers with symptoms of PTS and related physical problems; however, most primary care providers have not been trained to care for Veterans with PTS or communicate with them in ways that motivate them to engage in care.

In this study instigators propose to design, test and prepare to implement a Virtual World PTS and Motivational Interviewing training for primary care providers by taking the following steps: (1) partner with stakeholders to iteratively design the training which takes full advantage of the affordances of Virtual World technology to enhance training interactivity, effectiveness, and durability, (2) perform a randomized control trial to compare the virtual world training with an online training, and (3) summarize the findings and prepare for implementation and dissemination of the new training by soliciting feedback from primary care providers who participated in the training and from original project stakeholders.

Read the detailed description

The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans who have PTS symptoms after military service are often resistant to referrals to mental health care because of the warrior culture of stoicism coupled with the stigma of seeking mental health care. Also, Veterans living in rural or remote areas may not have access to trained mental health professionals. Thus, Veterans often present to their primary care providers with symptoms of PTS and related physical problems. Unfortunately, most primary care providers have not been trained to care for Veterans with PTS or communicate with them in ways that motivate them to engage in care. This can result in missed opportunities to intervene to prevent what may become chronic mental and physical health problems in the future, which affect not only the warfighter, but also their families, partners and children.

In a prior project funded by the Department of Defense (DoD), study investigators created and tested a web-based training program to teach primary care providers about how to assess for and manage PTS which proved successful in a small pilot study. Nevertheless, primary care providers who participated in the training reported that the training was not interactive and engaging enough and about 30% did not complete it. Moreover, the pilot study did not use gold standard methods to measure study outcomes and because project stakeholders, namely the Veterans Administration (VA) and the DoD, did not participate in the development of the training, investigators were not able to easily implement and disseminate it to primary care clinicians who work in these healthcare systems.

Virtual World technology is a three-dimensional immersive and highly interactive online experience in which users enter virtual environments as self-styled representations of themselves, known as avatars. Virtual Worlds are used in some of the most popular and engaging commercially-available video games. Virtual World technology is also increasingly being used for educational activities, particularly in learning about mental health problems and communication techniques. This is because experiences like mental health symptoms such as re-experiencing or intrusive thoughts (flashbacks) can be simulated, and participants (as avatars) can practice and receive feedback on new communication skills without feeling self-conscious. Learners can also practice motivational interviewing techniques such as using a stylized virtual scale to literally weigh the pros and cons (represented as blocks) of a particular behavior change. These interactive activities afforded by Virtual World technology can be used to make the learning experience far more memorable and enduring.

In this study, investigators propose to design, test and prepare to implement a Virtual World PTS and Motivational Interviewing training by taking the following steps: (1) partner with stakeholders to iteratively design the training so that is responsive to stakeholder needs and takes full advantage of the affordances of Virtual World technology to enhance training interactivity, effectiveness, and durability, (2) add a more robust evaluation component, including a randomized control trial with stronger provider and patient outcomes to achieve more valid results, and (3) summarize findings and prepare for implementation and dissemination of the new training by soliciting feedback from primary care providers who participated in the training and from original project stakeholders.

Being tested
Virtual World
Keywords
PTSD, Motivational Interviewing, veterans, military, virtual world, virtual reality, education, training, primary care, mental health
Medical subject headings
Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual WorldOther

    Participants will complete a synchronous PTSD training in an immersive virtual world environment.

Study groups in NCT03898271
Study groupRoleWhat they receive
Virtual World TrainingExperimentalSynchronous PTSD training in a virtual world environment
Receives: Other: Virtual World
Web-based Video TrainingActive comparatorAsynchronous web-based PTSD training
Receives: Other: Virtual World

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motivational Interviewing Treatment Integrity (MITI) Scale

    Use standardized patient interviews to observe change in Motivational Interviewing (MI) skills to assess and manage PTSD symptoms and to motivate engagement in care.

    Measured: 3 months

  2. PTSD Symptom Assessment and Management Scale

    Use standardized patient interviews to observe change in PTSD assessment and management clinical skills.

    Measured: 3 months

Secondary outcomes (3)
  1. Evaluation of PTSD Knowledge Questionnaire

    Use self-reported measures to observe change in PTSD related knowledge and change in self-reported use of PTSD knowledge after 90 days of no contact.

    Measured: 3 months

  2. Self-Efficacy Around PTSD Questionnaire

    Use self-reported measures to observe change in PTSD self-efficacy and change in self-reported PTSD self-efficacy after 90 days of no contact.

    Measured: 3 months

  3. Provider Satisfaction with Training Questionnaire

    Use self-reported measures to compare provider satisfaction with training in the virtual world training vs. the online video training

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start1 Oct 2015
  3. Primary completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03898271
Sponsor's protocol ID
14-15004
Acronym
VW
Status last verified
Oct 2020
First submitted
27 Mar 2019
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Samuelson KW, Koenig CJ, McCamish N, Choucroun G, Tarasovsky G, Bertenthal D, Seal KH. Web-based PTSD training for primary care providers: a pilot study. Psychol Serv. 2014 May;11(2):153-61. doi: 10.1037/a0034855. Epub 2013 Dec 23.

    PubMed 24364595
  • Manuel JK, Purcell N, Abadjian L, Cardoos S, Yalch M, Hill C, McCarthy B, Bertenthal D, McGrath S, Seal K. Virtual Worlds Technology to Enhance Training for Primary Care Providers in Assessment and Management of Posttraumatic Stress Disorder Using Motivational Interviewing: Pilot Randomized Controlled Trial. JMIR Med Educ. 2023 Aug 28;9:e42862. doi: 10.2196/42862.

    PubMed 37639299

Questions about this trial

What is this clinical trial studying?

A study testing Virtual World in people with Post Traumatic Stress Disorder, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motivational Interviewing Treatment Integrity (MITI) Scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03898271, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

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